The final version of ISO 13485:2016 is now available and companies should be planning their implementation. There are significant changes from the earlier version; they will require major modifications to the Quality Management System (QMS). The new version has better alignment with FDA's QSR, but there are still major differences that create issues for effective QMS implementation. This workshop covers the differences from the 2003 version to...

When medical device companies consider Agile development methods, they often run into the key criticism that Agile groups produce little to no documentation, and that Agile stands in contradiction to the lifecycle standards outlined in IEC 62304. In fact, those principles - have clear processes for quality management system, risk management process, software maintenance, configuration management, and problem resolution - actually augment rathe...

This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA is now fully enforced and the government is not using kid gloves any more. It will also address major changes under the Omnibus Rule and any other applicable updates for 2017 and beyond. There are an enormous amount of issues and risks for covered entities and business associates these days. I will speak on speci...

An essential task in any compliance analytics workflow is to not only explore your data visually, but also to communicate your results professionally with graphic displays. Do you have the tools and skills to quickly and thoroughly perform these tasks? This course in data visualization will present methods to allow you to interactively discover relationships graphically. We will provide the foundations for creating better graphical information...

To magnify the knowledge in the field of Microbiology and Biotechnology Set to take place on 21st and 23rd June 2017, the 4th annual event in the sell-out Pharmaceutical Microbiology series will bring together all levels of industry professionals, providing essential insights into the latest advancements in practice and technology, developments in regulation and the global harmonisation of evolving microbiology methods. Join us as we ask quest...

The CIO Government Technology will bring together leading CIOs, CISOs, and government IT executives from across the U.S. to confront and overcome current industry issues, cybersecurity, and cloud computing. This event will explore critical topics and challenges currently impacting government agencies, and emerging technologies that will resolve the issues. ​ The goal of the CIO Government Technology Conference is to create an environment...

Course "The New Clinical Trials Regulation and Regulatory Affairs Aspects of Medicinal Product Development in the EU" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. The main document from a regulatory perspective in the development of a medicinal product is the regulatory plan. In this Seminar it is explained how to write the regulatory plan, and which aspects to...

The Children’s Inn at NIH Ramps Up for Its Annual Charity Gala Bethesda, MD – January, 2017 – The Children’s Inn at the National Institutes of Health (NIH) today announced details for its 2017 ‘An Evening for Hope’ Gala. As The Inn’s official annual fundraising event, all net proceeds are donated to The Inn to provide a “Place Like Home” for children undergoing medical treatment at the NIH....

Pediatric Pathology 2017 will be an innovative and invigorating International conference reflecting the direction of Pediatric Pathology in the 21st century in a secure yet exciting environment that offers a wide range of diversions to participants of all backgrounds. This conference provides an excellent opportunity to discuss the latest developments within the field. Pediatric Pathology 2017 focuses around the theme “Clinical Advanceme...

Course Description In the past decade, the treatment of peritoneal metastases has gained interest from oncologic communities around the world. During the 1990’s, the first pioneering centers began treating patients with hyperthermic intraperitoneal chemotherapy (HIPEC). Prior to HIPEC, patients were treated with palliative support and only guaranteed a few months to live. Today, if a patient with peritoneal metastases is provided with pr...